P1368 - Topical Steroids for Eosinophilic Esophagitis: A Systematic Review and Meta-Analysis

Monday, October 25, 2021

10:30 AM – 4:15 PM PT

Location: Shoreline Exhibit Hall

Has Audio

Presenting Author(s)

Santosh Kale, MD

Nassau University Medical Center
East Meadow, NY, United States

Santosh Kale, MD¹, Charudatta Wankhade, MD¹, Bobby Jacob, MD¹, Rucha Jiyani, MD², Jiten Desai, MD¹, Rajmohan Rammohan, MD¹, Paul Mustacchia, MD, MBA¹
¹Nassau University Medical Center, East Meadow, NY; ²Nassau University Medical Center, Levittown, NY

Introduction: Eosinophilic Esophagitis (EoE) is the most common cause of food impaction with an estimated prevalence of 0.5-1 cases/1000 persons. Pharmacologic therapy consists of trial of PPI (Proton Pump Inhibitors) or topical steroids. Fluticasone and budesonide are the two most commonly used steroids and believed to decrease inflammation. The most recent meta-analysis with two studies concluded that budesonide viscous is the most effective steroid treatment for complete histologic remission. However, reporting analyses of one or two studies is not the best integration approach for a meta-analysis.

Methods: We performed a literature search using PubMed and CINAHL from inception through December 22, 2019. The following search strategy was used (eosinophilic oesophagitis OR eosinophilic esophagitis) AND (steroid OR steroids). All articles were individually reviewed by two people and disagreements were agreed upon by consensus. We included clinical trials which reported data on clinical or histological change after the use of topical steroids.

Results: In the absence of head-to-head comparisons of fluticasone and budesonide, we performed an indirect analysis with the available studies.

The meta-analysis for budesonide versus placebo clinical remission showed that budesonide had increased odds for clinical remission (OR:6.15, 95% CI: 1.63, 23.15) with 5 of 6 studies favoring budesonide.

Comparisons for budesonide versus placebo histological response showed that budesonide had increased odds for histological change (OR: 41.96, 95% CI: 13.09, 134.51) with all 5 studies favoring budesonide.

Our comparisons for fluticasone versus placebo histological response showed that fluticasone had increased odds for histological change (OR: 26.37, 95%CI: 5.69, 122.29) with all 3 studies favoring fluticasone.

Discussion: Overall, we found that budesonide has increased odds for clinical remission and histological change. Fluticasone had increased odds for histological change.

One of the limitations of our study is that there were no head-to-head comparison trials for comparison of budesonide with fluticasone. The trials included in our study were limited to the effect of budesonide or fluticasone to a placebo.

In conclusion, topical steroids including budesonide and fluticasone are effective for inducing histological change. Fluticasone is effective at bringing histological change but further trials are needed to study fluticasone and clinical response.

Figure: Flowchart of studies selection at each stage

Study/ Year	Design	Drug/ Dose and Duration of therapy	Number of Children	Number of Adults	Number of Males (%)	Histologic Diagnostic Criteria	Primary Histologic Endpoint	Clinical Endpoint	Study Duration	PPI trial done before & during the study
Budesonide suspension vs placebo
Dellon 2017	Modified ITT	Budesonide Oral Suspension 2 mg BID/12 weeks	35 Not equal to analysed	58	64 (68.81%)	> 15 eos/hpf	<6 eos/hpf (response)	Dysphagia Symptom Questionnaire (Validated)	12 weeks	Yes
Dohil 2010	Modified ITT	Oral Viscous Budesonide / 1-2 mg daily/ 3 months	23 –equal to analysed	0	20 (86.95 %)	> 20 eos/hpf	<6 eos/hpf (response)	Symptom Scoring Tool (Non – validated)	3 months	Yes
Gupta 2015	Modified ITT	Budesonide, Low (0.35 mg ), Medium (1.4 mg) & High Dose Suspension (2.8 mg)/12 weeks	71 equal to analyzed	None	57 (80.28%)	> 20 eos/hpf	< 6 eos/hpf (response)	EoE Clinical Symptom Score (Non-validated)	12 weeks	Yes
Lucendo 2019	ITT	Budesonide Oral Tablet 1 mg BID	None Equal to analysed	88	73 (82.95%)	> 20 eos/hpf	< 5 eos/hpf (defined as histologic remission only)	NRS for Dysphagia & Odynophagia Score (Validated)	6 weeks	Yes
Straumann 2010	ITT	Budesonide/ 1 mg BID Suspension /15 days	2 = analysed	34	31 (86.11%)	> 20 eos/hpf	< 4 eos/hpf (remission)	Dysphagia Score (non-validated)	15 days	N.A.
Miehlke 2016	Modified ITT (study stopped early)	Budesonide 2 mg Tablet, 4 mg tablet and Budesonide Viscous Solution	None = analysed	76	63 (82.89%)	> 16 eos/mm^2,and peak eosinophil > 65 /mm2 hpf	< 16 eos/mm²hpf (remission)	Dysphagia Score (Non – Validated)	2 weeks	Yes
Fluticasone vs placebo
Alexander 2012	ITT	Aerosolized Fluticasone /880 ug BID / 6 weeks	None = analysed	42	34 (80.95%)	>20 eos/hpf	More than 90% decrease in mean Eos count (response)	Validated Mayo Dysphagia Questionnaire	6 weeks	Yes
Butz 2014	Modified ITT (study stopped early)	Aerosolized Fluticasone / 1760 ug daily/ 3 months	29 Not equal to analysed	7	35	> 24 eos/hpf	< 1 eos/hpf (remission)	Symptoms of EoE (Semi Validated)	3 months	Yes
Konikoff 2006	Per protocol	Aerosolized Fluticasone /880 ug BID/3months	31 = analysed	None	26 (72.22%)	> 24 eos/hpf	< 1 eos/hpf (remission)	NA	3 months	Yes but usage before the study not mentioned

Table: Data Extraction Table

Note: ITT = Intention to Treat
NRS = Numerical Rating Scale
Eos/hpf = Eosinophils/ High Power Field

Due to no specific breakdown for baseline versus actual patients analyzed for many studies, the data for adults, children, and males includes patient baseline characteristics and not the smaller number of patients analyzed in the following studies: Dellon 2017, Butz 2014.

Disclosures:

Santosh Kale indicated no relevant financial relationships.

Charudatta Wankhade indicated no relevant financial relationships.

Bobby Jacob indicated no relevant financial relationships.

Rucha Jiyani indicated no relevant financial relationships.

Jiten Desai indicated no relevant financial relationships.

Rajmohan Rammohan indicated no relevant financial relationships.

Paul Mustacchia indicated no relevant financial relationships.

Santosh Kale, MD¹, Charudatta Wankhade, MD¹, Bobby Jacob, MD¹, Rucha Jiyani, MD², Jiten Desai, MD¹, Rajmohan Rammohan, MD¹, Paul Mustacchia, MD, MBA¹. P1368 - Topical Steroids for Eosinophilic Esophagitis: A Systematic Review and Meta-Analysis, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.